OriTex Oral Testosterone from Clarus Therapeutics


OriTex Oral Testosterone from Clarus Therapeutics
by Millard Baker

Clarus Therapeutics, a seven-year old company that is bleeding cash with practically no product revenue, is trying their luck at a new oral testosterone medication. The company is pinning its hopes on OriTex. OriTex is a new oral testosterone replacement treatment. Most individuals requiring testosterone replacement therapy (TRT) would prefer the ease and convenience of a pill over the messy testosterone gels or irritating testosterone patches or fear-provoking testosterone injections. Oral testosterone products have historically been beset with several problems. Methyltestosterone, one of the first attempts at an orally-active testosterone product, was beset with liver toxicity problems with long-term use. Even recent attempts, such as Andriol, have produced less-than-stellar therapeutic results for a high percentage of patients.

Clarus Therapeutics feels it has created a superior delivery method for testosterone even though OriTex is using the same testosterone compound – testosterone undecanoate – that is used in Andriol. William Llewellyn, of HRT-Rx, explains the different technology used by Clarus:

A new company called Clarus Therapeutics thinks it may have an answer. This firm has been funding clinical studies on a new formulation of testosterone undecanoate (TU) called a self-emulsifying drug delivery system (SEDDS). A study was published on the formulation just this week in the Journal of Andrology, and presented favorable results (1). Is it possible that an oral testosterone capsule is finally on its way to the U.S.?

Not only does Clarus feel that OriTex is superior to Andriol and other oral testosterone products, it also believes its product is superior to all other testosterone delivery methods on the market for testosterone replacement.

Convenient Dosing: OriTex is an easy-to-swallow softgel capsule expected to be taken twice daily with a meal, which we believe will be easier to use than T-replacement therapies currently on the market.
No Inadvertent T Exposure: OriTex is an oral product and thereby avoids the potential transference to women and children and related secondary exposure issues associated with the market leading T-gels.
Normalized T Levels: 77% and 87% of men treated with OriTex in our Phase II studies, respectively, obtained serum T levels within the normal range, defined as 300-1,000 ng/dL.
No Liver Toxicity: Because of the different chemical composition of TU, we did not observe any liver toxicity in our Phase II studies, particularly the kind of liver injury associated with oral methyl-T.
Safe Pharmacokinetic Profile: In our OriTex Phase II repeat-dose studies, the FDA guidance for acceptable peak serum T levels was met without any dose adjustment. In contrast to sustained high serum T levels observed for several days after dosing with injectable T, only three men treated with OriTex had an average serum T above the 1,000 ng/dL upper limit of normal. We believe avoiding T levels above this threshold can decrease the risk of potential side effects associated with high T levels, such as an increased risk of stroke and gynecomastia.

Clarus Therapeutics is betting heavily on the success of Oritex. Clarus Therapeutics registered for a $50 million Initial Public Offering with the U.S. Securities and Exchange Commission in January 2011. The IPO date has yet to be announced.

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